Definitions

Biohazardous materials or agents present have the potential to place the health of humans or animals at risk, either directly through infection or indirectly through damage to the environment.

Detailed instructions outlining the specific steps and safety precautions to be followed when handling biohazardous materials or performing laboratory procedures.  It addresses the systematic identification, assessment, and management of risks associated with the handling, storage, transportation, and disposal of biohazardous materials to minimize the potential for adverse outcomes, including exposures, infections, and environmental contamination.

A complete program of administrative controls, medical surveillance, vaccination, and containment strategies for promoting safe laboratory practices, procedures, and containment equipment to reduce the risk of disease to employees from potential occupational exposure to infectious agents or other biologically derived molecules.

A description of the degree of physical containment being employed to confine biohazardous materials and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment. In Appendix G of the NIH Guidelines, these are graded from BL-1 (the least stringent) to BL-4 (the most stringent) and are applicable to Select Agents and biotoxins.

Review of administrative and regulatory issues unrelated to the criteria for approval that under the NIH guidelines must be determined by a convened IBC. 

Individual who conducts the Biosafety Review.

Actions that pose substantive harm to the health or safety of personnel, students, the public or the environment or a serious deviation from either the established research protocol or those practices that are commonly accepted by the scientific community or could result in an adverse biosafety event. A violation may also occur when a PI demonstrates other serious or continued noncompliance with federal, state, or local laws, regulations, or policies.

• Allegation of Noncompliance: An unproven assertion of Noncompliance.
• Noncompliance: Failure to follow the NIH guidelines, local requirements, or determinations of the IBC.
• General Noncompliance: Deviation from the approved research protocol or practices commonly accepted by the scientific community.
• Continuing Noncompliance: A pattern of noncompliance that is likely to continue without intervention or failure to work with the IBC to resolve noncompliance.
• Corrective Action Plan (CAP): an outline of specific steps to be taken to remedy the cause of Noncompliance.
• Serious Noncompliance: Noncompliance violations which deviate from the approved research protocol and practices commonly accepted by the scientific community; negatively affect the integrity of the study, the rights and welfare of researchers, the general public, subjects and the environment; require revision to the approved protocol; and had the potential to result in an adverse biosafety event. The actions of the investigator pose a substantive harm to the health and/or safety of personnel, students, the institution, and/or the public environment.
• Need to Know Individuals: For Research Noncompliance: PI, IBC Chair, Chair of the Respondent’s department, applicable IO, DIEC, Office of the General Counsel, and Provost (if externally funded). For IBC Noncompliance: DIEC.

Protection of high-consequence microbial agents and toxins, or critical relevant information, against theft or diversion by those who intend to pursue intentional misuse.

Use of biologic agents or toxins (e.g., pathogenic organisms that affect humans, animals, or plants) for terrorist purposes.

The individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities, or in research requiring containment at BL-3 or BL-4. The duties of the BSO are described in section s IV-B-3 of the NIH Guidelines.

Samples of biological material, such as tissues, cells, blood, urine, saliva, feces or other bodily fluids, collected from humans, animals, plants, or microorganisms for research, diagnostic, or therapeutic purposes. Biological specimens are used to study physiological processes, identify disease biomarkers, develop diagnostic tests, and investigate the effects of environmental exposures.

Pathogenic microorganisms present in human blood that can cause diseases in humans, such as hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), syphilis, malaria, brucellosis, leptospirosis, Ebola, and Marburg viruses.

The federal agency requiring registration before any transfer or use of select agents can occur. The BSO and the EHS Director are the UMassD officials with the responsibility for ordering Select Agents.

The serial holders of a pathogen, each of whom is responsible for securing the pathogen and are accountable for its documentation.

All review processes which requires a convened IBC.

When a registration submission requires administrative revisions for the registration to be granted approval.

Any situation in which an individual (or the individual’s spouse, domestic partner, children, and/or dependents) is involved in research has a personal, professional, financial, or other interest that could potentially influence their objectivity, judgment, or decision-making regarding the review, approval, or oversight of research protocols. Conflicts related to research may involve the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family, including:

• Involvement in the design, conduct, or reporting of the research.
• Financial interests related to equity holdings, exclusive of interests through mutual funds, compensation related to the research in the preceding 12 months, or proprietary interests (patent, trademark, copyright or licensing agreement).
• Ownership interest, stock options, or other ownership interest of any value exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation of any amount in the past year or of any amount expected in the next year, excluding compensation for costs directly related to conducting research.
• Board or executive relationship, regardless of compensation.
• Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center.
• Affiliation with organizations, companies, or ventures related to the research that could result in a direct financial benefit.
• Personal or professional relationships with the researchers or sponsors or investigators of the research which could create bias or the appearance of bias.
• Any other circumstance that could reasonably be perceived as affecting the impartiality or integrity of the review process.

Disclosure of conflicts deemed related to research is essential for maintaining transparency, integrity, and public trust in the review and oversight of biohazardous material research conducted. Conflicts must be identified and managed appropriately to ensure that decisions are made in the best interests of safety, compliance, and ethical conduct. Conflict of interest must be disclosed at the beginning of review of any documents and meeting attendance.

The strategies and procedures implemented to prevent the unintentional release of biohazardous materials into the environment or exposure to laboratory workers and the public. Containment involves the continuous monitoring and evaluation of laboratory practices are necessary to identify areas for improvement and ensure compliance with biosafety standards. This includes regular inspections, audits, and reviews of containment facilities, procedures, and training programs.

Effective biosafety management requires collaboration among researchers, biosafety officers, and the IBC. Regular communication and coordination are essential for implementing and maintaining biosafety protocols, conducting risk assessments, and addressing emerging challenges.

The process of removing or neutralizing biohazardous materials from surfaces, equipment, or other items to reduce the risk of contamination and potential exposure.

An Experienced IBC member designated by the Chair, BSO, or RO to conduct a Non-Committee review.

Physical barriers, equipment, and design features implemented to minimize the risk of exposure to biohazardous materials, such as biological safety cabinets, fume hoods, and ventilation systems.

The systematic surveillance and assessment of laboratory environments for the presence of biohazardous materials, contaminants, and hazardous conditions to ensure the safety of personnel, facilities, and the surrounding community.

An IBC member who based on professional competence has sufficient knowledge and skill in conducting IBC reviews to serve as Designated Reviewer.

Some materials that are registered with the IBC are also controlled by U.S. Export Control regulations. These laws and regulations may require federal agency approval or a license before any controlled materials may be exported out of the U.S. or transferred to foreign persons within the U.S. The three federal government agencies responsible for implementing the export control regulations include: the Department of Commerce, the Department of State, and the Department of Treasury.

The process of isolating and copying a specific gene or DNA fragment from one organism and inserting it into another organism or vector to produce multiple copies of the gene for further study or manipulation. Gene cloning is a fundamental technique in molecular biology and genetic engineering.

The precise modification of DNA sequences within the genome of an organism using engineered nucleases or other molecular tools to insert, delete, or replace specific DNA sequences. Gene editing technologies, such as CRISPR-Cas9, allow targeted modifications to be made to the genome with unprecedented accuracy and efficiency.

The manipulation of an organism's genetic material using recombinant DNA technology to introduce new genetic material or alter existing genetic sequences. Genetic engineering techniques enable the creation of genetically modified organisms (GMOs) with desired traits for agricultural, medical, industrial, or research purposes.

The deliberate alteration or modification of the genetic material of an organism, typically using molecular biology techniques such as gene cloning, gene editing, or genetic engineering. Genetic manipulation allows scientists to study gene function, modify traits, produce genetically modified organisms (GMOs), and develop new biotechnological products and applications.

Hazard groups categorize biological agents based on their inherent hazard to human health and the environment. Hazard groups are typically used in biosafety and biosecurity practices to assess the potential risk associated with handling specific biological agents. Hazard groups consider factors such as the pathogenicity, virulence, mode of transmission, and potential for causing harm to humans and the environment.

Any waste material that poses a potential threat to human health or the environment due to its chemical, biological, radiological, or physical properties.

The deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into human research participants.

Pluripotent cells derived from the inner cell mass of early-stage embryos. These cells have the remarkable ability to self-renew indefinitely and to differentiate into various specialized cell types representing all three germ layers of the human body: ectoderm, mesoderm, and endoderm. Due to their unique characteristics, HESC hold significant potential for regenerative medicine, drug discovery, and disease modeling. However, their use is subject to strict ethical and regulatory guidelines to ensure responsible and ethical research practices.

The United States Department of Health and Human Services (HHS) is a cabinet-level department of the federal government responsible for protecting the health of all Americans and providing essential human services. HHS oversees a wide range of agencies and programs, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS), among others. Its mission encompasses public health, biomedical research, disease prevention, healthcare delivery, and social services, with the goal of promoting the well-being and health security of individuals and communities across the nation.

The process of rendering biohazardous materials non-infectious or non-viable through physical or chemical means, such as autoclaving, disinfection, or sterilization.

A documented plan outlining the strategies and procedures to be followed in the event of an emergency or biosafety incident, such as spills, exposures, or accidents, security breaches, and include notification protocols and emergency response actions. Effective plans are critical for mitigating risks and minimizing harm in the event of accidents or incidents.  Laboratories should have clear protocols in place for handling spills, exposures, or breaches in containment, including procedures for decontamination and medical response.

An agent capable of producing infection. Several factors are taken into consideration when evaluating risk, which include pathogenicity of the organism, mode of transmission and host range, availability of effective measures, and availability of treatment.

A public or private entity, including federal, state, and local governments.

The committee responsible for overseeing all animal care and use at UMassD and has adopted policies and procedures that apply to all vertebrate animals used for research and teaching.

A committee responsible for the review research involving recombinant DNA, biohazardous materials, select agents, and biologically derived toxins. The IBC also reviews other forms of research that include biohazardous risks as part of the assigned responsibilities.

An individual who signs, and has the authority to sign, on behalf of the Institution and make a commitment that the appropriate regulatory requirements will be met. 

The committee responsible for protecting the rights and welfare of all human subjects involved in research. Human subjects are defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.”

A comprehensive review and evaluation of laboratory facilities, operations, procedures, and practices conducted by internal or external auditors to assess compliance with regulatory requirements, institutional policies, and industry standards in biosafety and biosecurity.

Indicates the use of 10 liters or more of any one cell line or biological material.

The IBC member running a convened IBC meeting. The Meeting Chair may be an IBC Chair, Vice Chair, or an IBC member temporarily designated by a Chair.

The probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The government body is comprised of 27 separate Institutes and Centers, and is one of eight health agencies with the Public Health service, which is an agency within the U.S. Department of Health and Human Services. The goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability.

Outlines principles for the safe conduct of research employing recombinant DNA technology (created in1976). The NIH Guidelines detail practices and procedures for the containment of various forms of rDNA research, for the proper conduct of research involving genetically modified plants, bacteria, viruses, and animals, and for the safe conduct of human gene transfer research. The document keeps pace with the changing state of science.

Substances or particles with dimensions at the nanometer or micrometer scale, respectively, typically engineered or manufactured for specific applications in materials science, engineering, medicine, or biotechnology. Nanomaterials and microparticles exhibit unique physical, chemical, and biological properties due to their small size and high surface-to-volume ratio.

Also known as an autopsy or post-mortem examination, a necropsy is a thorough examination performed on the body of a deceased organism, typically an animal, to determine the cause of death, identify underlying diseases or injuries, and gather diagnostic information. Necropsies are commonly conducted in veterinary medicine, pathology, and research settings to study disease processes, assess treatment efficacy, and investigate unexpected deaths. The procedure involves the systematic examination of organs, tissues, and bodily fluids, often including gross observation, histological analysis, and microbiological testing. Necropsies play a crucial role in understanding disease pathogenesis, monitoring animal health, and informing clinical and research practices.

Information that:

• Is unexpected (inconsistent with the information previously reviewed by the IBC); and
• Indicates that researchers or others are at increased risk of harm because of the research study.

All review processes that do not require a convened IBC: non-biological research determinations, non-engagement determinations, exemption determinations, and expedited review.

Any reasonably anticipated skin, eye, mucous membrane, or parenteral contact with biohazardous materials that may result from the performance of an employee's duties.

The NIH office responsible for developing, implementing, and monitoring NIH policies and procedures for the safe conduct of rDNA activities, including human gene transfer.

Including the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, body fluid that is visibly contaminated with blood and all body fluids where it is difficult or impossible to differentiate between body fluids; any unfixed tissue from human and HIV/HBV containing culture medium.

Entry into the body by other means than through the digestive tract such as by piercing mucous membranes or the skin by needle sticks, human bites, cuts, and abrasions.

Clothing, gloves, goggles, face shields, respirators, or other equipment worn by laboratory personnel to protect against exposure to biohazardous materials.

Microorganisms, including bacteria, fungi, viruses, nematodes, and phytoplasmas, that cause diseases in plants, leading to crop losses, reduced yield, and economic damage in agriculture and horticulture. Plant pathogens can infect various parts of plants, including leaves, stems, roots, and fruits, and may spread through vectors, soil, water, or air. 

Any UMassD faculty member, or other authorized individual, who may serve as a project director/leader for activities that involve biological agents. The PI accepts full responsibility for all aspects of the project.

Abnormal, misfolded proteins that can induce the misfolding of normal proteins and cause a variety of neurodegenerative diseases, including Creutzfeldt-Jakob disease (CJD), variant CJD, and kuru, in humans and other animals. Prions are unique infectious agents that lack nucleic acids and are resistant to conventional sterilization methods.

A system of procedures and activities implemented to ensure that biosafety practices and protocols are effectively implemented, monitored, and continuously improved to meet established standards and regulatory requirements.

An NIH advisory committee whose principal role is to provide advice and recommendations to the NIH Director on 1) the conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines, and 2) other NIH activities pertinent to recombinant DNA technology. A major element of this role is to examine the science, safety, and ethics of clinical trials that involve the transfer of rDNA to humans.

Molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from their replication.

A facility official who has been designated the responsibility and authority to ensure that the requirements of 42CFR73, 9CFR121, and 7CFR331 are met, as appropriate, for the pathogen/toxin in use.

Research involving the manipulation of DNA molecules to create new combinations of genetic material not found in nature. Recombinant DNA techniques allow scientists to insert, delete, or modify genes from different organisms to study gene function, produce recombinant proteins, develop genetically modified organisms, and advance biotechnological applications.

The adherence to ethical principles, professional standards, and regulatory requirements in the planning, conduct, and reporting of biohazardous material research. Responsible conduct encompasses integrity, honesty, transparency, and accountability in all aspects of research activities, including experimental design, data collection and analysis, interpretation of results, authorship and publication practices, and adherence to relevant laws, regulations, and institutional policies. Researchers and institutional officials are expected to demonstrate responsible conduct to ensure the integrity and credibility of scientific research, protect the welfare of human subjects and animals, safeguard the environment, and maintain public trust in the research enterprise.

Actions that pose substantive harm to the health or safety of personnel, students, the public or the environment or a serious deviation from either the established research protocol or those practices that are commonly accepted by the scientific community or could result in an adverse biosafety event. A violation may also occur when a researcher demonstrates other serious or continued noncompliance with federal, state, or local laws, regulations, or policies.

When the initial, continuing, or modification registration submission does not meet the criteria for approval and the IBC considers the research to have extensive deficiencies to the protocol which must be addressed.

The systematic evaluation of potential hazards, exposures, and risks associated with specific activities, materials, or processes to determine appropriate control measures and mitigate potential risks to personnel, the environment, and public health.The systematic evaluation of potential hazards, exposures, and risks associated with specific activities, materials, or processes to determine appropriate control measures and mitigate potential risks to personnel, the environment, and public health.

The implementation of measures and controls to reduce or eliminate the likelihood and severity of potential risks associated with biohazardous materials research, laboratory activities, and operations.

Steadfast adherence to ethical principles and professional standards in all facets of scientific inquiry, encompassing honesty, accuracy, objectivity, and transparency from hypothesis formulation to the dissemination of findings. It entails upholding the highest standards of conduct, including responsible research practices, appropriate attribution of credit, and avoidance of conflicts of interest, to foster trust, credibility, and reliability in the scientific community and society at large.

Microorganisms or related toxins that have been specifically identified by the Federal Government as presenting a potential public health threat as agents of bioterrorism.  Identified and regulated as such, these agents carry additional regulatory burdens for safety and security. Specifically, regulated pathogens and toxins as defined in Title 42, CFR, Part 73, including pathogens and toxins regulated by both DHHS and USDA (i.e., overlapping agents or toxins) and plant pathogens regulated by USDA alone. In this document, “Select Agents (SA) pathogens” and “SA pathogens” refer to both select agent pathogens and toxins for all biosecurity purposes.

The ability to take physical possession of select agents/toxins. Such access includes areas where unlocked freezers, small unsecured, yet locked, containers, and cabinets contain select agents/toxins.

An area where select agents/toxins are used or stored, regardless of whether they are in locked containers. Such an area would be a laboratory room or connecting rooms where select agents are used or stored. Corridors outside the laboratory room where select agents are used or stored may or may not be declared a select agent area, depending upon the biosecurity plan approved by the RO.

Temporary or permanent withdrawal of IBC approval for some or all research procedures.

Artificially synthesized DNA or RNA molecules created using chemical synthesis techniques rather than being derived from living organisms. Synthetic nucleic acids can be designed to have specific sequences and properties for use in research, diagnostics, therapeutics, and biotechnology applications.

When a Committee Review determines further information is necessary to supplement the initial, continuing, or modification registration submission as its status does not meet the criteria for approval. Additionally, when registration submissions may be tabled when quorum is lost at Committee Review.

Withdrawal of IBC approval for all research procedures where the IBC does not anticipate re-opening the study.

Formal instruction and ongoing training programs provided to personnel to ensure they have the knowledge, skills, and competencies required to safely handle hazardous materials, operate equipment, and follow biosafety protocols.

An unexpected event that indicates an increased risk of harm due to the research study.

The USDA is a federal executive department responsible for developing and executing policies related to farming, agriculture, forestry, and food. The USDA's mission includes promoting agricultural trade, ensuring food safety, conserving natural resources, supporting rural communities, and providing nutrition assistance programs. The department oversees various agencies, including the Food Safety and Inspection Service (FSIS), the Agricultural Marketing Service (AMS), the Natural Resources Conservation Service (NRCS), and the Animal and Plant Health Inspection Service (APHIS), among others. Through its diverse programs and initiatives, the USDA plays a crucial role in enhancing the sustainability, productivity, and resilience of America's agricultural and food systems.

Diagrams or representations of recombinant DNA vectors used in molecular biology to illustrate the structure, organization, and key features of the vector, including the DNA sequences, restriction sites, selectable markers, and other genetic elements incorporated into the vector for cloning or gene expression purposes.

The proper handling, storage, and disposal of biohazardous waste generated during laboratory activities, in accordance with regulatory requirements and institutional policies.

The transplantation of living cells, tissues, or organs from one species (the donor) to another species (the recipient), typically involving the use of animal-derived tissues or organs in human patients. Xenotransplantation holds promise for addressing organ shortages and treating certain medical conditions but raises concerns about the risk of transmitting zoonotic diseases and immune rejection.

Infectious diseases caused by pathogens that can be transmitted between animals and humans, posing risks to both animal handlers and the general public.